Verapamil EG

Italy
Brand name Verapamil EG
Form tablets, modified release
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 032100
Manufacturer EG S.P.A.
Verapamil EG tablets, modified release

Package leaflet: Information for the patient

VERAPAMIL EG 120 mg modified-release tablets

Verapamil hydrochloride
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What VERAPAMIL EG is and what it is used for
  2. What you need to know before taking VERAPAMIL EG
  3. How to take VERAPAMIL EG
  4. Possible side effects
  5. How to store VERAPAMIL EG
  6. Contents of the pack and other information

1. What VERAPAMIL EG is and what it is used for

VERAPAMIL EG contains the active substance verapamil hydrochloride, which belongs to a group of
medicines called calcium channel blockers (calcium antagonists), which promote relaxation of the
heart and blood vessels.
VERAPAMIL EG is indicated for the treatment of:

  • heart problems due to reduced blood supply (acute and chronic coronary insufficiency);
  • abnormal heart rhythm disorders (supraventricular tachyarrhythmias such as paroxysmal supraventricular tachycardia, atrial fibrillation and atrial flutter with rapid ventricular response, extrasystoles);
  • high blood pressure (arterial hypertension).

This medicine is also indicated as a treatment following a heart attack (myocardial infarction) and to
prevent a subsequent heart attack in patients without signs of heart failure and when other medicines
(beta-blockers) cannot be used.

2. What you should know before taking VERAPAMIL EG

Do not take VERAPAMIL EG

  • if you are allergic to verapamil or to any of the other ingredients of this medicine (listed in section 6);
  • if you have a severe heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
  • if you recently had a heart attack and developed complications such as a markedly reduced heart rate (myocardial infarction complicated by marked bradycardia);
  • if your heart function is reduced below normal (left ventricular contractile dysfunction, decompensated congestive heart failure);
  • heart failure with ejection fraction below 35% and/or pulmonary pressure above 20 mm Hg (except if due to supraventricular tachycardia responsive to verapamil therapy);
  • if you have severe conduction disorders and irregular heartbeat (complete AV block, partial AV block; incomplete bundle branch block, sick sinus syndrome, except in patients with an implanted ventricular pacemaker; second- or third-degree AV block, except in patients with a functioning implanted ventricular pacemaker), wide-complex ventricular tachycardia, atrial fibrillation/flutter with concomitant Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome, or short PR syndromes);
  • if you have a very slow heart rate (marked bradycardia with less than 50 beats/minute);
  • if you have low blood pressure (hypotension with systolic pressure below 90 mm Hg) (see section “Warnings and precautions”);
  • if you are taking medicines used to treat depression (MAO inhibitors), or for heart conditions (quinidine-type treatments), or for high blood pressure (beta-blockers) (see section “Other medicines and VERAPAMIL EG”);
  • if you are taking a medicine containing ivabradine used to treat certain heart conditions (see section “Other medicines and VERAPAMIL EG”).

Warnings and precautions
Talk to your doctor or pharmacist before taking VERAPAMIL EG.
Do not take VERAPAMIL EG if your heart function is severely reduced below normal (severe left ventricular dysfunction). If you have a mild form of this disorder, your doctor may prescribe other medicines (digitalis and/or diuretics) before starting treatment with this medicine.
During treatment with this medicine, the following may occur:

  • a drop in blood pressure below normal levels, which may cause dizziness or other symptoms related to low blood pressure (symptomatic hypotension);
  • a transient increase in liver enzymes (transaminases), with or without an increase in other blood substances (alkaline phosphatase, bilirubin). You should undergo periodic liver function tests during treatment with this medicine;
  • a negative inotropic effect (reduced force of heart contraction): if you have heart failure, your doctor will need to decide on appropriate compensation and initiate suitable therapy before starting verapamil treatment.

Take VERAPAMIL EG with caution and inform your doctor if:

  • you have a specific heart condition called Wolff-Parkinson-White syndrome or Lown-Ganong-Levine syndrome. In such cases, your condition may worsen (very rapid ventricular response or ventricular fibrillation);
  • you have heart diseases related to conduction disorders, as verapamil acts on the AV and SA nodes and prolongs AV conduction time: development of second- or third-degree AV block requires discontinuation of treatment and, if necessary, initiation of appropriate therapy;
  • you have liver problems. In this case, your doctor will periodically monitor your heart function and may decide to adjust the dose (generally, patients with severe liver impairment receive a lower dose, about 30% of the usual dose);
  • you have kidney problems, as this may affect your heart. Your doctor will monitor you periodically to assess heart function;
  • you have a very slow heart rate (bradycardia) or low blood pressure (hypotension) (see section “Do not take VERAPAMIL EG”);
  • you have severe muscle disorders (myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy).

Children and adolescents
There are no data available on the safety and efficacy of modified-release verapamil tablets in children and adolescents; therefore, use of this medicine is not recommended in children and adolescents.

Other medicines and VERAPAMIL EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Specific monitoring may be required if you are taking other medicines.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

  • alpha-blockers, medicines used to treat high blood pressure and to help urination in patients with benign prostatic hyperplasia (terazosin, prazosin);
  • medicines used to treat heart rhythm disorders (quinidine, flecainide, dronedarone);
  • theophylline, a medicine used to treat asthma;
  • dabigatran etexilate and sulfinpyrazone, medicines used to prevent blood clots (thrombi);
  • carbamazepine and phenytoin, medicines used to treat epilepsy (anticonvulsants);
  • imipramine, a medicine used to treat depression;
  • glyburide, a medicine used to treat diabetes;
  • medicines used to treat bacterial infections (clarithromycin, erythromycin, rifampicin, telithromycin);
  • doxorubicin, a medicine used to treat certain types of cancer;
  • phenobarbital, a medicine used to induce anesthesia and to treat epilepsy;
  • medicines used to treat anxiety and to promote sleep (buspirone, midazolam);
  • beta-blockers (metoprolol, propranolol), medicines used to treat high blood pressure and certain heart conditions;
  • digitalis (digitoxin, digoxin), medicines used to treat heart problems (heart failure) (see section “Warnings and precautions”);
  • cimetidine, a medicine used to treat stomach and intestinal problems such as acidity or ulcers;
  • medicines used after organ transplantation (cyclosporine, everolimus, sirolimus, tacrolimus);
  • medicines used to lower high blood lipid levels (atorvastatin, lovastatin, simvastatin);
  • almotriptan, a medicine used to treat migraine;
  • St. John’s wort (Hypericum perforatum), used to treat depression;
  • medicines used to treat AIDS (anti-HIV agents);
  • medicines used for anesthesia (neuromuscular blocking agents and inhaled anesthetics);
  • acetylsalicylic acid, a medicine used to treat pain, fever, and inflammation or to prevent blood clot formation (thrombi);
  • other medicines used to treat high blood pressure (e.g., vasodilators, angiotensin-converting enzyme inhibitors, and diuretics);
  • disopyramide, a medicine used to prevent and treat certain heart rhythm disorders. Do not take disopyramide within 48 hours before or 24 hours after administration of VERAPAMIL EG;
  • lithium, a medicine used to treat certain mental disorders;
  • aliskiren, a medicine used to treat high blood pressure.

Avoid taking VERAPAMIL EG if you are taking:

  • colchicine, a medicine used to prevent and treat joint inflammation (gouty arthritis);
  • ivabradine, used to treat certain heart conditions (angina pectoris, chronic heart failure);
  • dantrolene (infusion), a medicine used to treat a muscle disorder called malignant hyperthermia.

VERAPAMIL EG with food and alcohol
Avoid consuming grapefruit juice and alcoholic beverages during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary and under direct medical supervision.
Do not take this medicine while breastfeeding, as verapamil passes into breast milk. If you need to take this medicine, breastfeeding must be discontinued, as serious adverse effects may occur in the infant.

Driving and using machines
This medicine may impair your ability to drive or operate machinery, especially at the beginning of treatment, when the dose is increased, when your doctor changes your therapy (switching from other medicines to VERAPAMIL EG), or when you consume alcohol.

VERAPAMIL EG contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take VERAPAMIL EG

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet in the morning and 1 tablet in the evening (240 mg/day) for the
treatment of heart circulation disorders (moderately severe coronary insufficiency) and for the
prevention of heart rhythm disorders (tachyarrhythmias).
If necessary, this dose may be increased to 2 tablets twice daily (480 mg/day).
If you take more VERAPAMIL EG than you should
Symptoms of overdose may include low blood pressure (hypotension),
reduced heart rate (bradycardia) up to heart activity blockage (high-grade AV block and sinus arrest),
high blood sugar levels (hyperglycaemia), feeling tired and uninterested (apathy), increased blood acidity (metabolic acidosis).
Following ingestion of very high doses (overdose), death has occurred.
If you accidentally ingest or take an excessive dose of VERAPAMIL EG, inform your doctor immediately or go to the nearest hospital.
If you forget to take VERAPAMIL EG
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

  • dizziness, headache;
  • slow heart beat (bradycardia);
  • low blood pressure (hypotension);
  • sensation of warmth (hot flushes);
  • constipation;
  • nausea;
  • swelling in the arms and legs due to fluid accumulation (peripheral oedema);

Uncommon (may affect up to 1 in 100 people)

  • increased awareness of heart beats (palpitations);
  • increased heart rate (tachycardia);
  • abdominal pain;
  • fatigue.

Rare (may affect up to 1 in 1,000 people)

  • tingling sensation in arms and legs (paraesthesia);
  • tremor;
  • somnolence;
  • perception of ringing in the ears (tinnitus);
  • vomiting;
  • increased sweating (hyperhidrosis).

Frequency not known (frequency cannot be estimated from the available data)

  • allergic reactions (hypersensitivity);
  • seizures;
  • increased potassium levels in the blood (hyperkalaemia);
  • movement disorders (extrapyramidal disorders);
  • paralysis (tetraparesis) when verapamil is taken concomitantly with colchicine (see section “Other medicines and VERAPAMIL EG”);
  • dizziness;
  • serious heart problems (atrioventricular block, sinus bradycardia, sinus arrest, heart failure, asystole);
  • difficulty in breathing (bronchospasm and dyspnoea);
  • serious intestinal problems (ileus);
  • swelling of the gums (gingival hyperplasia);
  • abdominal discomfort;
  • swelling of the face, extremities, lips, tongue, mouth and/or throat (angioedema);
  • severe skin disorders (purpura, Stevens-Johnson syndrome, erythema multiforme, maculopapular rash);
  • hair loss (alopecia);
  • skin eruptions (urticaria, rash), itching;
  • muscle weakness, muscle pain (myalgia), joint pain (arthralgia);
  • kidney problems (renal failure);
  • sexual dysfunction (erectile dysfunction);
  • breast enlargement in men (gynaecomastia);
  • milk secretion (galactorrhoea);
  • changes in certain blood tests performed to monitor liver function (increased liver enzymes), increased levels of a hormone (prolactin);
  • changes in blood sugar levels (impaired glucose tolerance).

If you experience serious side effects such as a marked drop in blood pressure (severe hypotension) or serious heart conduction problems (complete AV block), contact your doctor immediately. He or she will advise you on appropriate treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VERAPAMIL EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What VERAPAMIL EG contains

  • The active substance is verapamil hydrochloride. Each modified-release tablet contains 120 mg of verapamil hydrochloride.
  • The other components are: sodium alginate, povidone, lactose, magnesium stearate, Opadry Orange (talc, titanium dioxide, polyvinyl alcohol, PEG 3350, iron oxides and lakes).

Description of the appearance of VERAPAMIL EG and pack contents
Pack containing 30 tablets.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan
Manufacturer
Lamp San Prospero S.p.A., Via della Pace, 25/A, 41030 San Prospero (MO)

Package leaflet: information for the patient

Verapamil EG 240 mg modified-release tablets

Verapamil hydrochloride
Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Verapamil EG is and what it is used for
  2. What you need to know before taking Verapamil EG
  3. How to take Verapamil EG
  4. Possible side effects
  5. How to store Verapamil EG
  6. Contents of the pack and other information

1. What VERAPAMIL EG is and what it is used for

VERAPAMIL EG contains the active substance verapamil hydrochloride, which belongs to a group of
medicines called calcium channel blockers (calcium antagonists), which help relax the heart and blood vessels.
VERAPAMIL EG is indicated for the treatment of high blood pressure (mild to moderate arterial hypertension).

2. What you should know before taking VERAPAMIL EG

Do not take VERAPAMIL EG

  • if you are allergic to verapamil or to any of the other ingredients of this medicine (listed in section 6);
  • if you have a severe heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
  • if you recently had a heart attack and developed complications such as a markedly slow heart rate (myocardial infarction complicated by marked bradycardia);
  • if your heart function is significantly reduced (left ventricular contractile insufficiency, decompensated congestive heart failure);
  • heart failure with ejection fraction below 35% and/or pulmonary pressure above 20 mm Hg (except if due to supraventricular tachycardia responsive to verapamil therapy);
  • if you have severe conduction disorders and irregular heartbeat (complete AV block, partial AV block; incomplete bundle branch block, sick sinus syndrome, except in patients with a functioning artificial ventricular pacemaker; second- or third-degree AV block, except in patients with a functioning artificial ventricular pacemaker, wide-complex ventricular tachycardia, atrial fibrillation/flutter with concomitant Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome, or short PR syndromes);
  • if you have a very slow heart rate (marked bradycardia with less than 50 beats/minute);
  • if you have low blood pressure (hypotension with systolic pressure below 90 mm Hg) (see section “Warnings and precautions”);
  • if you are taking medicines used to treat depression (MAO inhibitors), or for heart conditions (quinidine-type treatments), or for high blood pressure (beta-blockers) (see section “Other medicines and VERAPAMIL EG”);
  • if you are taking a medicine containing ivabradine used to treat certain heart conditions (see section “Other medicines and VERAPAMIL EG”).

Warnings and precautions
Talk to your doctor or pharmacist before taking VERAPAMIL EG.
Do not take VERAPAMIL EG if your heart function is severely reduced (severe left ventricular dysfunction). If you have a mild form of this condition, your doctor may prescribe other medicines (digitalis and/or diuretics) before starting treatment with this medicine.
During treatment with this medicine, the following may occur:

  • a drop in blood pressure below normal levels, which may cause dizziness or other symptoms related to low blood pressure (symptomatic hypotension);
  • transient increase in liver enzymes (transaminases), with or without increases in other blood substances (alkaline phosphatase, bilirubin). Periodic liver function tests should be performed during treatment with this medicine;
  • a negative inotropic effect (reduced heart contractility): if you have heart failure, your doctor must decide on appropriate compensation and initiate adequate therapy before starting verapamil.

Take VERAPAMIL EG with caution and inform your doctor if:

  • you have a specific heart condition called Wolff-Parkinson-White syndrome or Lown-Ganong-Levine syndrome. In these cases, your condition may worsen (very rapid ventricular response or ventricular fibrillation);
  • you have heart diseases related to conduction problems, as verapamil acts on AV and SA nodes and prolongs AV conduction time: development of second- or third-degree AV block requires discontinuation of treatment and, if necessary, initiation of appropriate therapy;
  • you have liver problems. In this case, your doctor will monitor your heart function periodically and may decide to adjust the dose (generally, patients with severe liver impairment receive a lower dose, about 30% of the usual dose);
  • you have kidney problems, as this may affect your heart. Your doctor will monitor your heart function periodically;
  • you have a very slow heart rate (bradycardia) or low blood pressure (hypotension) (see section “Do not take VERAPAMIL EG”);
  • you have severe muscle disorders (myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy).

Children and adolescents
There are no available data on the safety and efficacy of verapamil modified-release tablets in children and adolescents; therefore, the use of this medicine is not recommended in children and adolescents.

Other medicines and VERAPAMIL EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Specific monitoring may be required if you are taking other medicines.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

  • alpha-blockers, medicines used to treat high blood pressure and to help urine elimination in patients with benign prostatic hyperplasia (terazosin, prazosin);
  • medicines used to treat heart rhythm disorders (quinidine, flecainide, dronedarone);
  • theophylline, a medicine used to treat asthma;
  • dabigatran etexilate and sulfinpyrazone, medicines used to prevent blood clots (thrombi);
  • carbamazepine and phenytoin, medicines used to treat epilepsy (anticonvulsants);
  • imipramine, a medicine used to treat depression;
  • glyburide, a medicine used to treat diabetes;
  • medicines used to treat bacterial infections (clarithromycin, erythromycin, rifampicin, telithromycin);
  • doxorubicin, a medicine used to treat certain types of cancer;
  • phenobarbital, a medicine used to induce anesthesia and to treat epilepsy;
  • medicines used to treat anxiety and to promote sleep (buspirone, midazolam);
  • beta-blockers (metoprolol, propranolol), medicines used to treat high blood pressure and certain heart conditions;
  • digitalis (digitoxin, digoxin), medicines used to treat heart problems (heart failure) (see section “Warnings and precautions”);
  • cimetidine, a medicine used to treat stomach and intestinal problems such as acidity or ulcers;
  • medicines used after organ transplantation (cyclosporine, everolimus, sirolimus, tacrolimus);
  • medicines used to lower high blood lipid levels (atorvastatin, lovastatin, simvastatin);
  • almotriptan, a medicine used to treat migraine;
  • St. John’s wort (Hypericum perforatum), used to treat depression;
  • medicines used to treat AIDS (anti-HIV agents);
  • medicines used for anesthesia (neuromuscular blockers and inhaled anesthetics);
  • acetylsalicylic acid, a medicine used to treat pain, fever, and inflammation or to prevent blood clots (thrombi);
  • other medicines used to treat high blood pressure (e.g., vasodilators, angiotensin-converting enzyme inhibitors, and diuretics);
  • disopyramide, a medicine used to prevent and treat certain heart rhythm disorders. Do not take disopyramide within 48 hours before or 24 hours after administration of VERAPAMIL EG;
  • lithium, a medicine used to treat certain mental disorders;
  • aliskiren, a medicine used to treat high blood pressure.

Avoid taking VERAPAMIL EG if you are taking:

  • colchicine, a medicine used to prevent and treat joint inflammation (gouty arthritis);
  • ivabradine, used to treat certain heart conditions (angina pectoris, chronic heart failure);
  • dantrolene (infusion), a medicine used to treat a muscle disorder called malignant hyperthermia.

VERAPAMIL EG with grapefruit juice and alcohol
Avoid consuming grapefruit juice and alcoholic beverages during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary and under strict medical supervision.
Do not take this medicine while breastfeeding, as verapamil passes into breast milk. If you need to take this medicine, breastfeeding must be discontinued because serious adverse effects may occur in the infant.

Driving and using machines
This medicine may impair your ability to drive or operate machinery, especially at the beginning of treatment, when the dose is increased, when your doctor changes your therapy (switching from other medicines to VERAPAMIL EG), or if you consume alcohol.

VERAPAMIL EG contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take VERAPAMIL EG

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The dose of VERAPAMIL EG 240 mg tablets should be adjusted according to the individual patient. The blood pressure-lowering effects of this medicine become evident within the first
week of treatment.
The recommended daily dose is 1 tablet (240 mg) in the morning with food.
Your doctor may reduce the initial dose to 120 mg daily, taken in the morning, for example if you are elderly or of small body size.
Your doctor may subsequently increase the dose as follows:

  • 1 tablet (240 mg) every morning, plus 1 tablet of VERAPAMIL EG 120 mg tablets (120 mg) every evening;
  • 1 tablet (240 mg) every 12 hours.

If you take more VERAPAMIL EG than you should
Symptoms of overdose may include low blood pressure (hypotension),
slow heart rate (bradycardia) up to complete heart block (high-grade AV block and sinus arrest), high blood sugar levels (hyperglycaemia), feeling tired and uninterested (apathy), increased blood acidity (metabolic acidosis). Death has occurred following ingestion of very high doses (overdose).
If you accidentally ingest or take an excessive dose of VERAPAMIL EG, contact your doctor immediately or go to the nearest hospital.
If you forget to take VERAPAMIL EG
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

  • dizziness, headache;
  • slow heart rate (bradycardia);
  • low blood pressure (hypotension);
  • sensation of warmth (hot flushes);
  • constipation;
  • nausea;
  • swelling of arms and legs due to fluid accumulation (peripheral edema);

Uncommon (may affect up to 1 in 100 people)

  • increased awareness of heartbeat (palpitations);
  • increased heart rate (tachycardia);
  • abdominal pain;
  • fatigue.

Rare (may affect up to 1 in 1,000 people)

  • tingling sensation in arms and legs (paraesthesia);
  • tremor;
  • somnolence;
  • perception of ringing in the ear (tinnitus);
  • vomiting;
  • increased sweating (hyperhidrosis).

Frequency not known (frequency cannot be estimated from the available data)

  • allergic reactions (hypersensitivity);
  • seizures;
  • increased potassium levels in the blood (hyperkalemia);
  • movement disorders (extrapyramidal disorders);
  • paralysis (tetraparesis) when verapamil is taken concomitantly with colchicine (see section “Other medicines and VERAPAMIL EG”);
  • dizziness;
  • serious heart problems (atrioventricular block, sinus bradycardia, sinus arrest, heart failure, asystole);
  • difficulty breathing (bronchospasm and dyspnea);
  • severe intestinal problems (ileus);
  • gum swelling (gingival hyperplasia);
  • abdominal discomfort;
  • swelling of the face, extremities, lips, tongue, mouth and/or throat (angioedema);
  • severe skin disorders (purpura, Stevens-Johnson syndrome, erythema multiforme, maculopapular rash);
  • hair loss (alopecia);
  • skin eruptions (urticaria, rash), itching;
  • muscle weakness, muscle pain (myalgia), joint pain (arthralgia);
  • kidney problems (renal failure);
  • sexual dysfunction (erectile dysfunction);
  • breast enlargement in men (gynecomastia);
  • milk secretion (galactorrhea);
  • changes in certain blood tests performed to monitor liver function (increased liver enzymes), increased levels of a hormone (prolactin);
  • changes in blood sugar levels (impaired glucose tolerance).

If you experience serious side effects such as a marked decrease in blood pressure (severe hypotension) or serious heart conduction problems (complete AV block), contact your doctor immediately. He or she will advise you on appropriate treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VERAPAMIL EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

VERAPAMIL EG 240 mg modified-release tablets

  • The active substance is verapamil hydrochloride. Each modified-release tablet contains 240 mg of verapamil hydrochloride.
  • The other components are: sodium alginate, povidone, lactose, magnesium stearate, Opadry Green (talc, titanium dioxide, polyvinyl alcohol, PEG 3350, iron oxides and lakes).

Description of the appearance of VERAPAMIL EG and pack sizes
Pack size: 30 tablets.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan
Manufacturer
Lamp San Prospero S.p.A., Via della Pace, 25/A, 41030 San Prospero (MO)